Status:
COMPLETED
Obsidio™ Conformable Embolic Registry
Lead Sponsor:
Boston Scientific Corporation
Conditions:
Hypervascular Tumors
Bleeding
Eligibility:
All Genders
18+ years
Brief Summary
OCCLUDE is a prospective, post-approval, open-label, single arm, multi-center US registry of patients who undergo embolization with Obsidio™ Conformable Embolic. The purpose of this Registry is to ass...
Eligibility Criteria
Inclusion
- Patient is ≥ 18 years of age
- Signed informed consent\*
- Patient is to undergo or has undergone embolization with Obsidio™ Conformable Embolic
- Patient is willing and able to comply with protocol requirements, including all procedures, clinical evaluations, and follow-up visits \*Patients being treated for control of bleeding/hemorrhage who are unable to consent prior to their procedure, can be enrolled if the informed consent is provided and signed within 72 hours of the index procedure
Exclusion
- Patient has a life expectancy \< 30 days
- Contraindications to receiving Obsidio™ Conformable Embolic per the Instructions For Use (IFU)
- Embolization for uterine fibroids, prostate artery, genicular artery, ovarian vein, spermatic vein, pulmonary arteriovenous malformations, bronchial artery, asymptomatic benign tumors, portal vein, varices, lymphatic/thoracic duct, nonvascular channel (e.g. ureter, intestinal fistula)
- Patients with more than 2 discrete lesions, defined as a treatment area that may be fed by one or more vessels
Key Trial Info
Start Date :
June 19 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 9 2025
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06170619
Start Date
June 19 2024
End Date
September 9 2025
Last Update
December 22 2025
Active Locations (20)
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1
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
2
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
3
St. Joseph's Medical Center
Stockton, California, United States, 95204
4
Christiana Hospital
Newark, Delaware, United States, 19718